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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Recognition 12/23/2016 
FR Recognition Number 1-119
Standard
ISO 14408 Third edition 2016-02-15
Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
Scope/Abstract
ISO 14408:2016 specifies marking, labelling, and information to be supplied by the manufacturer for cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§868.5740 Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Class 2 CBI
§868.5730 Tube, Tracheal (W/Wo Connector) Class 2 BTR
§868.5730 Tube, Tracheal, Reprocessed Class 2 NMA
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Deepika Lakhani
  FDA/OMPT/CDRH/ODE/DAGID/RPDB/
  301-796-4042
  Deepika.Lakhani@fda.hhs.gov
 William C. Maloney
  FDA/OMPT/CDRH/OSB/DPS/MDR/
  301-796-6272
  William.Maloney@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
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